Pharmacokinetics, Pharmacodynamics Profile and Tolerance of HRS-9231 in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: HRS-9231; Drug: Placebo

• Registration Number: NCT07123376
• Lead Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd

Brief Summary

To evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics of HRS-9231 injection in a single dose in healthy subjects

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Primary Completion: 2024-10-06
• Study Completion: 2024-10-06
• Status Verified: 2025-08
• Study First Submitted: 2025-08-08
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age between 18 to 45 years.
2. Body mass index (BMI) of 19.0 to 28.0 kg/m2 (inclusive).
3. Understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (ICF).

Exclusion Criteria

1. Patients with contraindications for magnetic resonance imaging (MRI) examinations.
2. During the screening period, those whose 12-lead electrocardiogram examination is judged by clinical doctors as abnormal and of clinical significance will be selected.
3. Those with a history of drug abuse, drug use, or positive results in drug abuse screening.
4. Unable to tolerate venipunctures or have a history of fainting needles and blood.
5. People with various urinary disorders (such as frequent urination, difficulty in urination, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 1	HRS-9231	8 healthy subjects were to be included
Group 1	Placebo	8 healthy subjects were to be included
Group 2	HRS-9231	8 healthy subjects were to be included
Group 2	Placebo	8 healthy subjects were to be included
Group 3	HRS-9231	8 healthy subjects were to be included
Group 3	Placebo	8 healthy subjects were to be included
Group 4	HRS-9231	8 healthy subjects were to be included
Group 4	Placebo	8 healthy subjects were to be included
Group 5	HRS-9231	8 healthy subjects were to be included
Group 5	Placebo	8 healthy subjects were to be included

Primary Outcome Measures

Name	Time	Method
Adverse events, serious adverse events	From ICF signing date to Day10

Secondary Outcome Measures

Name	Time	Method
Cl = total clearance	From baseline (1 hour before injection) to 12 hours post-injection
Cmax：maximum concentration measured. Blood samples were taken to assess HRS-9231 concentration	From baseline (1 hour before injection) to 12 hours post-injection
t1/2 = terminal elimination half-life of the compound	From baseline (1 hour before injection) to 12 hours post-injection

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China